A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery

Pulmonary Disease, Chronic Obstructive Clinical Trial

— CHAMPION  

Official title:

China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313361
• Other study ID #: CR108767
• Secondary ID: NOPRODLUC4001
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: December 9, 2021

Study information

• Verified date: January 2022
• Source: Johnson & Johnson (China) Investment Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the smoking cessation methods and services patients received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants who have been scheduled for an elective lung surgery by the treating physician's judgement, due to the following conditions: known lung cancer, COPD, a pulmonary lesion (example. nodule, ground glass opacity) or other pulmonary conditions

• Smokers who are or were smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years within 3 months prior to the scheduled surgery, or recent smoking quitters with a history of smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years, who quit smoking between 3 months and 5 years prior to the scheduled surgery

• Being willing to participate the study and sign the participant informed consent form (ICF)

Exclusion Criteria:

• Participants who have emergency lung surgery due to accident or injury

• Participants are not likely to be able to complete the 6-month follow-up after the lung surgery

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No intervention
No drug will be administered as part of this study.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson (China) Investment Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery	Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.	Baseline Prior to the Surgery
Primary	Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery	Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.	Baseline Prior to the Surgery
Primary	Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery	Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.	Month 1 post-surgery
Primary	Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery	Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.	Month 3 post-surgery
Primary	Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery	Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.	Month 6 post-surgery
Primary	Number of Smoking Cessation Attempts at Baseline Prior to the Surgery	Number of smoking cessation attempts at baseline prior to the surgery will be reported.	Baseline prior to the surgery
Primary	Number of Smoking Cessation Attempts at Month 1 Post-surgery	Number of smoking cessation attempts at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Number of Smoking Cessation Attempts at Month 3 Post-surgery	Number of smoking cessation attempts at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Number of Smoking Cessation Attempts at Month 6 Post-surgery	Number of smoking cessation attempts at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline	Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.	Baseline
Primary	Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery	Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery	Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery	Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery	Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.	Baseline prior to surgery
Primary	Percentage of Participants Using NRTs at Month 1 Post-surgery	Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Participants Using NRTs at Month 3 Post-surgery	Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery	Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.	Month 6 post-surgery
Primary	Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery	Percentage of participants with self-reported smoking abstinence and 7-days/30-day point prevalence of smoking at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery	Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery	Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Percentage of Participants with Smoking Relapse at Month 1 Post-surgery	Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Participants with Smoking Relapse at Month 3 Post-surgery	Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Participants with Smoking Relapse at Month 6 Post-surgery	Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status	Overall incidence of PCs and PPCs post-surgery (at 1 day prior to discharge) and by baseline smoking status will be reported.	At 1 day prior to discharge
Primary	Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status	Overall incidence of PCs and PPCs post-surgery (within 2 weeks after surgery) and by baseline smoking status will be reported.	Within 2 weeks after surgery
Primary	Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status	Overall incidence of PCs and PPCs post-surgery (within 1 month post-surgery) and by baseline smoking status will be reported.	Within 1 month post-surgery
Primary	Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status	Overall incidence of PCs and PPCs post-surgery (within 3 months post-surgery) and by baseline smoking status will be reported.	Within 3 months post-surgery
Primary	Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status	Overall incidence of PCs and PPCs post-surgery (within 6 months post-surgery) and by baseline smoking status will be reported.	Within 6 months post-surgery
Primary	Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery	Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.	Baseline prior to surgery
Primary	Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery	Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery	Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery	Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery	Percentage of specific smoking cessation methods and service participants received from HCPs at baseline prior to surgery will be reported.	Baseline prior to surgery
Primary	Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery	Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery	Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery	Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.	Month 6 post-surgery
Primary	Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery	Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at baseline prior to surgery will be reported.	Baseline prior to surgery
Primary	Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery	Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 1 post-surgery will be reported.	Month 1 post-surgery
Primary	Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery	Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 3 post-surgery will be reported.	Month 3 post-surgery
Primary	Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery	Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 6 post-surgery will be reported.	Month 6 post-surgery